Effect of low-dose spironolactone on resistant hypertension in type 2 diabetes mellitus: a randomized controlled trial in a sub-Saharan African population

Romance Nguetse Djoumessi, Jean Jacques N Noubiap, Francois Folefack Kaze, Mickael Essouma, Alain Patrick Menanga, Andre Pascal Kengne, Jean Claude Mbanya, Eugene Sobngwi, Romance Nguetse Djoumessi, Jean Jacques N Noubiap, Francois Folefack Kaze, Mickael Essouma, Alain Patrick Menanga, Andre Pascal Kengne, Jean Claude Mbanya, Eugene Sobngwi

Abstract

Background: Low-dose spironolactone has been proven to be effective for resistant hypertension in the general population, but this has yet to be confirmed in type 2 diabetic (T2DM) patients. We assessed the efficacy of a low-dose spironolactone on resistant hypertension in a sub-Saharan African population of T2DM patients from Cameroon.

Methods: This was a four-week single blinded randomized controlled trial in 17 subjects presenting with resistant hypertension in specialized diabetes care units in Cameroon. They were randomly assigned to treatment with a daily 25 mg of spironolactone (n = 9) or to an alternative antihypertensive regimen (n = 8), on top of any ongoing regimen and prevailing lifestyle prescriptions. They were seen at the start of the treatment, then 2 and 4 weeks later. The primary outcome was change in office and self-measured blood pressure (BP) during follow-up, and secondary outcomes were changes in serum potassium, sodium, and creatinine levels.

Results: Compared with alternative treatment, low-dose spironolactone was associated with significant decrease in office systolic BP (-33 vs. -14 mmHg; p = 0.024), and in diastolic BP (-14 vs. -5 mmHg; p = 0.006). After 1 month of spironolactone, all the patients were controlled based on BP below 130/80 mmHg, with significant office BP reduction from 158 ± 17/86 ± 11 to 125 ± 11/72 ± 8, vs. 158 ± 8/94 ± 8 to 144 ± 17/89 ± 12 mmHg in the alternative treatment group. There was no significant variation in sodium and creatinine levels in both groups, but a mild increase of potassium levels in the spironolactone group.

Interpretation: Add-on low-dose spironolactone was effective in reducing BP to optimal levels in T2DM Cameroonian patients despite mild increase in serum potassium. Trial registration ClinicalTrials.gov Identifier NCT02426099. Date of registration April 2015.

Keywords: Cameroon; Resistant hypertension; Spironolactone; Sub-Saharan Africa; Type 2 diabetes mellitus.

Figures

Fig. 1
Fig. 1
Trial profile
Fig. 2
Fig. 2
Distribution of individual variation of serum sodium and potassium in each group after intervention
Fig. 3
Fig. 3
Individual variation of serum creatinine after intervention

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